Annulus repair systems and methods

ABSTRACT

Systems and methods for repairing annulus defects include scaffold ( 30 ), attachment members ( 40 ), and anchors ( 20 ). The scaffold ( 30 ) acts as a plug to substantially fill the annulus defect. The anchors ( 20 ) are secured to tissue adjacent the annulus defect. The attachment member ( 40 ) secures the scaffold ( 30 ) to the anchors ( 2 ). Thus, the systems and methods for repairing annulus defects retain the scaffold within the annulus defect.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of the filing date of U.S.Provisional Application No. 60/243,941 filed on Oct. 27, 2000.

BACKGROUND OF THE INVENTION

The present invention relates generally to the field of spinal surgery,and more particularly to systems and methods for repairing the annulusfibrosis of a spinal disc.

There are various surgical procedures that create a defect in theannulus fibrosis, such as, for example, an annulotomy, a discectomy,nucleotomy, implantation of artificial disc nucleus or artificial discprosthesis, or repair of a disc herniation. Repair of annulus defects isnormally perceived as time consuming and ineffective. Thus, annulusdefects are commonly left unrepaired. This may lead to a higherincidence of disc reherhiation or expulsion of the implant from the discspace.

In those procedures where the annulus is repaired via sutures thatattempt to close the defect by pulling the surrounding tissue together,there are difficult challenges encountered. Typically, the annulusdefect is a large hole that can be five millimeters or larger indiameter. The size of the hole makes it very difficult to close withconventional suturing techniques since it is difficult to activelyengage the sutures in the surrounding annulus tissues. The sutures canalso cut or tear through the annulus tissues after the repair has beenmade.

The prior art includes a surgical device for sealing a biologicalaperture in situ that is made from a porous expandable material. Onedisadvantage, however, is that the device could possibly move in theaperture or become dislodged from the aperture.

What is therefore needed is a system and method for spinal surgery whichprovides a quick and effective repair for defects in the annulusfibrosis which will remain in the defect after placement to seal theopening and/or promote healing. The present invention is directed towardmeeting this need, among others.

SUMMARY OF THE INVENTION

The present invention is directed to systems and methods for repairingannulus defects. Embodiments of the system include scaffolds, attachmentmembers, and anchors. The scaffold acts as a plug to substantially fillthe annulus defect. The anchors are secured to the vertebral bodies oneach side of the disc space. The attachment members secure the scaffoldto the anchors.

According to one aspect of the invention, a method for repairing anannulus defect provided. One or more anchors are secured to each of theupper and lower vertebral bodies adjacent the annulus defect site. Oneor more attachment members are then attached to the anchors. It iscontemplated that the attachment members can be attached to the anchorseither before or after the anchors are secured to the vertebral bodies.One or more tissue scaffolds are then attached to the attachmentmembers. It is also contemplated that the tissue scaffolds can beattached to the attachment members either before or after the attachmentmembers are attached to the anchors. The scaffold is then inserted intothe annulus defect, and the attachment members manipulated to secure thescaffold to the anchors.

In one form of the invention, the scaffold is compressible for insertioninto the annulus defect. When the scaffold returns to its normal relaxedstate, it substantially seals or fills the defect. An attachment memberextends through the scaffold and attaches the scaffold anchors engagedto the adjacent vertebrae.

According to another aspect of the invention, an annulus repair systemis provided. One embodiment of the annulus repair system includes ascaffold having an attachment portion. In one form, anchors are used tosecure the attachment portion to the adjacent vertebral bodies. Inanother form, sutures secure the attachment portion to the annulustissue surrounding the defect. In a further form, the attachment portionis secured to the adjacent vertebral bodies and also to the annulustissue surrounding the defect.

According to a further aspect of the invention, a non-porous material ispositionable in an annulus defect and incorporates into the naturaltissue ingrowth.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is directed to one embodiment of an annulus repair systemaccording to one aspect of the present invention.

FIG. 2 is the annulus repair system of FIG. 1 positioned in a defect ina spinal disc annulus.

FIGS. 3( a)-3(c) illustrate various embodiments of anchors usable withthe system of FIG. 1.

FIGS. 4( a)-4(f) illustrate various embodiments of a scaffold usablewith the system of FIG. 1.

FIGS. 5( a)-5(d) illustrate various steps of one embodiment of a methodfor repairing an annulus defect using the system of FIG. 1.

FIGS. 6( a) and 6(b) illustrate a side elevational view and aperspective view, respectively of one embodiment of a tissue scaffoldhaving an attachment portion according to another aspect of the presentinvention.

FIGS. 7( a) and 7(b) illustrate the tissue scaffold of FIGS. 6( a) and6(b) inserted in an annulus defect having an attachment portion securedto the annulus tissue around the defect.

FIGS. 8( a)-8(d) illustrate various embodiments of a tissue scaffoldhaving an attachment portion for anchoring to bony or hard tissues.

FIGS. 9( a)-9(d) illustrate various embodiments of a tissue scaffoldhaving an attachment portion for anchoring to soft tissues.

FIGS. 10( a)-10(d) illustrate various embodiments of a tissue scaffoldhaving an attachment portion for anchoring to both hard and softtissues.

FIGS. 11( a)-11(d) illustrate various tissue scaffolds in an annulusdefect having an attachment portion anchored to the adjacent vertebralbodies.

FIGS. 12( a)-12(f) illustrates various steps of a method forming atissue scaffold having an attachment portion from a sheet of fabric ornon-woven mesh.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to embodiments illustrated in thedrawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended, such alterations and furthermodifications in the illustrated device, and such further applicationsof the principles of the invention as illustrated therein beingcontemplated as would normally occur to one skilled in the art to whichthe invention relates.

The annulus repair system and methods include a tissue scaffold retainedby an attachment mechanism within a defect in the annulus fibrosis of aspinal disc. For example, the tissue scaffold substantially fills adefect or void within the annulus fibrosis, such as may be caused bysurgery or disc herniation. The tissue scaffold includes a soft tissueingrowth structure whereby the soft tissue grows through the tissuescaffold and occludes the defect or void. The attachment mechanism isconnectable with the tissue scaffold and with anchoring mechanisms. Theanchoring mechanisms may be fixedly attached to soft tissue and/or hardtissue or bone adjacent to the defect or void. Thus, the attachmentmechanism retains the tissue scaffold in a substantially fixed positionwithin the defect or void relative to adjacent soft or hard tissue.

The scaffold comprises structure that facilitates the formation ofnatural tissues in the defect space. The scaffold can be resorbable,partially resorbable, or non-resorbable. The tissue scaffold can be anyone of or combination of rigid, semi-rigid, compliant, resilient,elastic, compressible, expandable, and/or flexible. The scaffold can beporous, non-porous, or partially porous. For example, the scaffold maybe porous, and can be formed from an open or closed cell foam, rolled upwoven fabric or non-woven mesh, or braided or woven structures.Additionally, the scaffold may be capable of assuming various shapesthat generally conform with the annulus defect. Growth factors or cellscan be incorporated into or contained in the scaffold to accelerate theannulus repair process by tissue ingrowth or formation. Growth factorscan be transforming growth factor β1, insulin-like growth factor 1,platelet-derived growth factor, fibroblast growth factor, bonemorphogenetic protein, and combinations thereof.

In one embodiment the scaffold comprises a non-porous compositestructure with at least one resorbable phase and at least onenon-resorbable phase. The resorbable and non-resorbable phases areintermingled to form a uniform but heterogeneous material. Theresorbable phase is gradually replaced by natural tissues while thenon-resorbable phase is incorporated into natural tissue for fixation inorder to repair and reinforce the defect. One example of thenon-resorbable phase is a three-dimensional woven structure with a meshsize appropriate for cell migration (50-500 microns.) Further examplesof non-resorbable materials are provided below. The voids in and/oramong the non-resorbable phase are filled with resorbable material.Examples of non-resorbable materials are provided below.

The non-porous tissue scaffold can initially be relatively rigid forinsertion. As the resorbable phase absorbs body fluid in vivo, thetissue scaffold becomes more compliant. The non-porous tissue scaffoldis gradually incorporated as the resorbable phase is replaced by naturaltissue. The tissue scaffold may not be porous as the space originallyoccupied by the resorbable phase is replaced by natural tissue as theresorbable material is resorbed or removed in vivo. Growth factors orcells can be incorporated into the resorbable phase to further promotetissue ingrowth.

The scaffold can be suturable and tear-resistant, and can be made fromany biocompatible material, material of synthetic or natural origin, andmaterial of a resorbable or non-resorbable nature. Suitable examples ofscaffold material include autograft, allograft or xenograft; tissuematerials including soft tissues, connective tissues, demineralized bonematrix and combinations thereof; resorbable materials includingpolylactide, polyglycolide, tyrosine-derived polycarbonate,polyanhydride, polyorthoester, polyphosphazene, calcium phosphate,hydroxyapatite, bioactive glass, collagen, albumin, fibrinogen andcombinations thereof; and non-resorbable materials includingpolyethylene, polypropylene, polyester, polyvinyl alcohol,polyacrylonitrile, polyamide, polytetrafluorethylene, poly-paraphenyleneterephthalamide, cellulose, and combinations thereof.

In another form, the scaffold can be of the type discussed in U.S. Pat.No. 6,224,630 which is incorporated herein by reference in its entirety.

The anchors described herein can be made from any biocompatiblematerial, including synthetic or natural autograft, allograft orxenograft tissues, and can be resorbable or non-resorbable nature.Examples of tissue materials include hard tissues, connective tissues,demineralized bone matrix and combinations thereof. Further examples ofresorbable materials are polylactide, polyglycolide, tyrosine-derivedpolycarbonate, polyanhydride, polyorthoester, polyphosphazene, calciumphosphate, hydroxyapatite, bioactive glass, and combinations thereof.Further examples of non-resorbable materials are carbon-reinforcedpolymer composites, shape-memory alloys, titanium, titanium alloys,cobalt chrome alloys, stainless steel, and combinations thereof. It isfurther contemplated that the anchors of the present invention can beany device securable within hard tissue or soft tissue and connectablewith a scaffold and/or attachment member.

The attachment members can be any biocompatible material, such assutures, tethers, cords, planar members, band, wire, cable, mesh, sheet,braid, or any other elongate member capable of retaining the scaffoldwithin an annulus defect and connectable to tissue or to an anchor.Further, attachment member 40 can be resorbable or non-resorbable.Additionally, attachment member and anchors may be combined into asingle or integral device.

Referring now to FIG. 1 there is illustrated annulus repair system 15according to one embodiment of the present invention. The annulus repairsystem 15 includes a pair of anchors 20, a scaffold 30, and anattachment member 40 movably connectable with scaffold 30 and pair ofanchors 20. It should be understood that additional pairs of anchors 20along with additional attachment members 40 could be provided andconnected with scaffold 30.

In another embodiment, one or more attachment members 40 can movablyconnect one or more artificial disc members N′ to scaffold 30 and/oranchors 20. It is contemplated that artificial disc members N′ can be anartificial disc nucleus or disc prosthesis, fusion device or some otherdevice that has been inserted into the disc space through defect X inisolation or in combination with one or more other artificial members.Attachment member 40 can extend through the body of artificial discmember N′ or through one or more preformed holes.

Referring now to FIG. 2, there is shown a sectional view of a spinalcolumn segment including annulus A, nucleus N, upper vertebra V1 andlower vertebra V2. Annulus A includes an annulus defect X. Annulusrepair system 15 is shown with scaffold 30 positioned in annulus defectX and secured to the adjacent vertebral bodies V1 and V2. Scaffold 30includes a first inner end 34 adjacent to or in contact with nucleus Nand second outer end 35 generally aligned with the outer surface ofannulus A. Anchors 20 are embedded in a respective one of the vertebralbodies V1, V2 through the cortical rim. Attachment member 40 has beenpulled through scaffold 30 in order to tightly secure scaffold 30 to theanchors 20.

It is contemplated that defect X in annulus A may have been created inorder to perform an annulotomy, discectomy, nucleotomy or some otherprocedure in the disc space, or the defect X has resulted due to aging,trauma, degenerative condition, or the like. It is further contemplatedthat nucleus N can be the natural spinal disc nucleus pulposis, or canbe an artificial disc nucleus or disc prosthesis, fusion device or someother device that has been inserted into the disc space through defectX. The portion of annulus A surrounding defect X and extending aroundthe nucleus N is substantially intact, or has been repaired using thesystem and method of the present invention or some other known annulusrepair technique.

It is contemplated that scaffold 30 has a length between first end 34and outer end 35 sufficient to contact nucleus N and extend throughdefect X to the outer surface of annulus A. The height of scaffold 30between vertebral bodies V1 and V2, and the width of scaffold 30 alongannulus A, is such that scaffold 30 occupies all or substantially all ofdefect X, thereby effectively sealing defect X.

Referring now to FIGS. 3( a)-3(c), various embodiments of anchor 20 areillustrated. In FIG. 3( a) anchor 20 a has shank 22 a having a hole 26 aformed at one end thereof and an opposite pointed end 28 a to facilitatepenetration into the vertebral body. A thread form 24 a is providedalong shank 22 a to facilitate rotatable insertion of anchor 20 a, andalso to resist pullout from the vertebral body once inserted therein. InFIG. 3( b), anchor 20 b is provided having a shank 22 b with a hole 26 bat one end and an opposite pointed end 28 b. A number of barbs 24 bextend radially and outwardly from shank 22 b. Barbs 24 b preferablyhave a downward slope toward hole 26 b to resist pull out of anchor 20 bfrom the vertebral body. In FIG. 3( c), anchor 20 c includes shank 22 chaving a hole 26 c at one end and an opposite pointed end 28 c. A pairof gulls 24 c extend outwardly and downwardly from shank 22 c towardshole 26 c. Gulls 24 c are preferably pivotable so that gulls 24 c arepositioned along shaft 22 c during insertion of anchor 20 c, and thenpivot outwardly to the configuration shown in FIG. 3( c) uponapplication of a pullout force so that gulls 24 c resist pullout ofanchor 20 c from the vertebral body.

Referring now to FIGS. 4( a)-4(f), various embodiments of scaffold 30are provided. In FIG. 4( a) tissue scaffold 30 a has a body 32 a with acylindrical shape extending between a first end 34 a and an oppositesecond end 35 a. In FIG. 4( b) scaffold 30 b has a body 32 b with aracetrack or oval shape extending between a first end 34 b and anopposite second end 35 b. In FIG. 4( c) tissue scaffold 30 c has body 32c with a tapered shape that reduces in size as it extends between afirst end 34 c and an opposite second end 35 c. In FIG. 4( d) tissuescaffold 30 d has a body 32 d with a hexagonal shape extending between afirst end 34 d and an opposite second end 35 d. In FIG. 4( e) tissuescaffold 30 e has a body 32 e with a circular shape that tapers in sizebetween a first end 34 e and an opposite second end 35 e to form anoverall hourglass shape having a reduced size mid-portion. In FIG. 4( f)tissue scaffold 30 f has a body 32 f with a circular shape that tapersin size between a first end 34 f and an opposite reduced size second end35 f. It is contemplated that first end 34 f is positioned adjacent toor in contact with nucleus N, and the larger size of first end 34 fresists pushout of body 32 f from the annulus defect X. Such anchorscould have a funnel shape, mushroom shape, or umbrella shape.

In each of the illustrated embodiments in FIGS. 4( a)-4(f), it iscontemplated that scaffold 30 is inserted into the defect in the annulussuch that one of the end surfaces 34 or 35 is positioned adjacent thenucleus and the other end surface is positioned along the outer surfaceof the annulus. It also contemplated that scaffold 30 can be providedwith a length that does not extend completely along the length of thedefect through the annulus, but rather has an inner end spaced fromnucleus N and/or an opposite end that is recessed in the annulus withrespect to the outer surface of the annulus.

Referring now to FIGS. 5( a)-5(d), various steps of one embodiment of amethod using the system of FIG. 1 are shown. In FIG. 5( a) first bore 50is formed in upper vertebral V1 and a second bore 50 is formed in lowervertebral V2. Anchor bores 50 may be formed at annulus defect X andthrough the cortical rim of the vertebral end plate of the respectivevertebral body. It is also contemplated that bores 50 could be formed atother locations suitable for securing the anchors, such as through thesidewalls of the vertebral bodies. Annulus repair system 15 may then bepre-assembled in a manner as shown in FIG. 1, such that anchors 20 andanchors 30 are movably connected to attachment member 40. In FIG. 5( b)anchors 20 are placed in respective ones of the anchor bores 50. In FIG.5( c) attachment member 40 has been pulled through scaffold 30, andscaffold 30 positioned into annulus defect X. Scaffold 30 can becompressed or otherwise deformed in order to facilitate insertion intoannulus defect X, whereby scaffold 30 returns towards its uncompressedor undeformed configuration to substantially occupy and/or seal defectX. In FIG. 5( d) attachment member 40 is tied or otherwise fixed tosecure scaffold 30 in the desired position in defect X. It is alsocontemplated that anchors 20 can be first embedded into bores 50 withoutattachment member 40 attached thereto. Attachment member 40 and scaffold30 are then attached to the embedded anchors 20. It is furthercontemplated that more than one anchor can be embedded in eachvertebrae, and that more than one attachment member can be used tosecure scaffold 30 to the one or more embedded anchors.

Referring now to FIGS. 6-12, other forms of the scaffold will bedescribed. The scaffolds of FIGS. 6-12 are similar to scaffold 30described above, however, the scaffolds of FIGS. 6-12 further include anattachment portion extending from the body portion of the scaffold fordirect attachment of the scaffold to the hard and/or soft tissueadjacent the annulus defect. The scaffolds and anchors used with thescaffolds of FIG. 6-12 can be made from the same materials andcombinations of materials as scaffolds and anchors discussed above.

FIGS. 6( a) and 6(b) provide an elevational view and perspective view,respectively, of one embodiment of a tissue scaffold having anattachment portion. Scaffold 55 includes a scaffold body portion 56insertable in annulus defect X. Body portion 56 has an inner first end58 positionable towards nucleus N and an opposite outer second end 59 ofbody portion 56 generally alignable with the outer surface of theannulus tissue surrounding the defect. Scaffold 55 includes anattachment portion 57 connected to or formed with second end 59 thatextends outwardly from body portion 56. Attachment portion 57 ispreferably flexible and securable to the annulus tissue or the vertebralbodies adjacent to defect X.

Referring to FIGS. 7( a) and 7(b), scaffold 55 having attachment portion57 laterally oriented is shown with body portion 56 positioned inannulus defect X. The attachment portion 57 extends along the outersurface of annulus tissue A. Attachment portion 57 is secured to annulustissue A surrounding annulus defect X via sutures 90 to maintain thepositioning of scaffold 55 in the defect.

Referring now to FIGS. 8( a) through 8(d), various embodiments of tissuescaffold 55 having an attachment portion connectable to hard tissue,such as the bony vertebral bodies V1 and V2, is provided. The attachmentportions can be secured to the vertebral bodies adjacent annulus defectX via anchors to maintain the positioning of scaffold 55 in the defect.

In FIG. 8( a) scaffold 60 a includes a scaffold body portion 62 aextending between an inner end and an outer end and an attachmentportion 63 a extending from the outer end of body portion 62 a.Attachment portion 63 a includes an upper tab 64 a having a rectangularshape extending upwardly from body portion 62 a and lower tab 65 ahaving a rectangular shape extending downwardly from body portion 62 a.Upper tab 64 a includes a pair of upper holes 66 a, and lower tab 65 aincludes a pair of lower holes 67 a. Anchors, screws, staples pins orother attachment means positionable through holes 66 a, 67 a can be usedto secure the attachment portion to vertebrae V1 and V2. As shown inFIG. 11( a), an anchor in the form of staples 20 e are positionedthrough the tabs to secure scaffold 60 a to vertebrae V1, V2. In FIG.11(b) an anchor in the form of screws 20 d are positioned through theholes in the tab to secure scaffold 60 a to vertebrae V1, V2.

In FIG. 8( b) scaffold 60 b includes a scaffold body portion 62 bextending between an inner end and an outer end and an attachmentportion 63 b extending from the outer end of body portion 62 b.Attachment portion 63 b includes an upper tab 64 b having asemi-circular shape extending upwardly from body 62 b and lower tab 65 bhaving a semi-circular shape extending downwardly from body portion 62b. Upper tab 64 b includes an upper hole 66 b, and lower tab 65 bincludes lower hole 67 b. Anchors, staples, screws, pins or otherattachment means positionable through holes 66 b, 67 b can be used tosecure the attachment portion to vertebrae V1, V2. As shown in FIG. 11(a), staples 20 e are positioned through the tabs to secure scaffold 60 bto vertebrae V1, V2. In FIG. 11( b) screws 20 d are positioned throughthe holes in the tabs to secure scaffold 60 b to vertebrae V1, V2.

In FIG. 8( c) scaffold 60 c includes a scaffold body portion 62 cextending between an inner end and an outer end and an attachmentportion 63 c extending from the outer end of body portion 62 c.Attachment portion 63 c includes an upper tab 64 c having asemi-circular shape extending upwardly from body 62 c and a lower tab 65c having a semi-circular shape extending downwardly from body portion 62c. Suture anchors, screws, pins or staples or other attachment meanspositionable through the upper and lower tabs 64 c, 65 c can be used tosecure the attachment portion to vertebra V1, V2. As shown in FIG. 11(a), staples 20 e are positioned through the tabs to secure scaffold 60 cto vertebrae V1, V2. In FIG. 11( b) screws 20 d are positioned directlythrough the tabs to secure scaffold 60 c to vertebrae V1, V2.

In FIG. 8( d) scaffold 60 d includes a scaffold body portion 62 dextending between an inner end and an outer end and an attachmentportion 63 d extending from the outer end of body portion 62 d.Attachment portion 63 d includes an upper tab 64 d having an elongated,reduced width shape extending upwardly from body 62 d and a lower tab 65d having an elongated, reduced width shape extending downwardly frombody portion 62 d. As shown in FIG. 11( c), these elongated, reducedwidth tabs can be attached to or engaged by an embedded anchor, such asthe gull anchor 20 d, with the attachment member partially embedded intovertebrae V1, V2 along with the anchor. In yet another form, the upperand lower tabs can be pushed into bores formed in vertebrae V1, V2, andheld in place in the bore by positioning an anchor in the bore alongsidethe tab, such as threaded interference anchor 20 f shown in FIG. 11( d).

In FIGS. 9( a) through 9(d), there are shown various further embodimentsof scaffold 55 having an attachment portion connectable to the adjacentannulus tissue surrounding annulus defect X. In FIG. 9( a) scaffold 70 aincludes a scaffold body portion 72 a extending between an inner end andan outer end and an attachment portion 73 a extending from the outer endof body portion 72 a. Attachment portion 73 a includes a first lateraltab 74 a having a rectangular shape extending outwardly from body 72 aand an opposite second lateral tab 75 a having a rectangular shapeextending outwardly from body portion 72 a. Lateral tabs 74 a, 75 a canbe engaged to the annulus tissue adjacent annulus defect X with sutures,staples, or other suitable attachment means.

In FIG. 9( b) scaffold 70 b includes a scaffold body portion 72 bextending between an inner end and an outer end and an attachmentportion 73 b extending from the outer end of body portion 72 b.Attachment portion 73 b includes a first lateral tab 74 b having asemi-circular shape extending outwardly from body 72 b and an oppositesecond lateral tab 75 b having a semi-circular shape extending outwardlyfrom body portion 72 b. Lateral tabs 74 b, 75 b can be engaged to theannulus tissue adjacent annulus defect X with sutures, staples, or othersuitable attachment means.

In FIG. 9( c) scaffold 70 c includes a scaffold body portion 72 cextending between an inner end and an outer end and an attachmentportion 73 c extending from the outer end of body portion 72 c.Attachment portion 73 c includes a first lateral tab 74 c having asemi-circular shape that tapers to a reduced height at body portion 72c, and an opposite second lateral tab 75 c having a semi-circular shapeextending outwardly from body portion 72 c that also tapers to a reducedheight at body portion 72 c. The tapered lateral tabs 74 c, 75 c form afigure eight shaped attachment portion 73 c. Lateral tabs 74 c, 75 c canbe engaged to the annulus tissue adjacent annulus defect X with sutures,staples, or other suitable attachment means.

In FIG. 9( d) scaffold 70 d includes a scaffold body portion 72 dextending between an inner end and an outer end and an attachmentportion 73 d extending from the outer end of body portion 72 d.Attachment portion 73 d includes a first lateral tab 74 d having a pairof laterally extending flanges 76 d at the end of the tab opposite bodyportion 72 d. Attachment portion 73 d also includes an opposite secondlateral tab 75 d having a pair of laterally extending flanges 77 d atthe end of the tab opposite body portion 72 d. The lateral flanges onlateral tabs 74 d, 75 d provide extensions that add perimeter length forsuture attachment. Lateral tabs 74 d, 75 d can be engaged to the annulustissue adjacent annulus defect X with sutures, staples, or othersuitable attachment means.

Referring now to FIGS. 10( a) through 10(d) various embodiments of ascaffold are provided with attachment portions for securement to bothhard tissue and soft tissue using the anchors and/or sutures asdiscussed above. Such attachment portions include any member orcombinations of members respectively securable to hard tissue and softtissue, and in any configuration for retaining a scaffold within anannulus defect.

In FIG. 10( a) scaffold 80 a has a body portion 82 a and an attachmentportion 83 a extending from the outer end of body portion 82 a.Attachment portion 83 a has an upper tab 84 a and an opposite lower tab85 a for securement to hard tissue. Upper tab 84 a has a hole 88 a toreceive an anchor, and lower tab 85 a has a hole 89 a to receive ananchor. Attachment portion 83 a also includes opposite laterallyextending tabs 86 a, 87 a for attachment to the soft tissue surroundingthe defect. The upper and lower tabs and lateral tabs together form anoctagonal shape.

In FIG. 10( b) scaffold 80 b has a body portion 82 b with attachmentportion 83 b extending from the outer end of body portion 82 b.Attachment portion 83 b has an upper tab 84 b and an opposite lower tab85 b. The upper and lower tabs 84 b, 85 b include holes 88 b, 89 b,respectively, to receive an anchor. Attachment portion 83 b alsoincludes first lateral tab 86 b and opposite second lateral tab 87 b forattachment to the soft tissue surrounding the defect. In thisembodiment, the upper and lower tabs and lateral tabs together form across shape.

Referring now to FIG. 10( c) scaffold 80 c has body portion 82 c withattachment portion 83 c extending from the outer end of body portion 82c. Attachment portion 83 c includes an upper tab 84 c having hole 88 cto receive an anchor. Attachment portion 83 c has a lower tab 85 chaving a hole 89 c to receive an anchor. Attachment portion 83 c furtherincludes first lateral tab 86 c and opposite second lateral tab 87 c forattachment to the soft tissue surrounding the defect. In thisembodiment, the upper and lower tabs and the lateral tabs together forman arcuate or curvilinear cross-type shape.

Referring now to FIG. 10( d) scaffold 80 d has a body portion 82 d withan attachment portion 83 d extending from the outer end of body portion82 d. Attachment portion 83 d includes upper tab 84 d and lower tab 85d. Tabs 84 d, 85 d have an elongated, reduced width configuration forembedding into the vertebrae V1, V2 as discussed above with respect tothe embodiment of FIG. 8( d) and as shown in FIGS. 11( c) and 11(d).Attachment portion 83 d also includes first lateral portion 86 d andopposite lateral portion 87 d for attachment to the soft tissuesurrounding the annulus defect.

With respect to the various embodiments of the scaffold having anattachment portion described above, the attachment portion can be joinedor fixed to the body portion of the scaffold using various techniques.These techniques include, for example, sewing the attachment portion tothe scaffold, thermal welding or bonding, adhesive bonding, threedimensional weaving or braiding, screws, staples, pins, tacks or rivetfixation, or forming the scaffold from existing continuous materialssuch as folding a sheet of fabric or non woven mesh. Furthermore, theattachment portion can be secured to the body portion of the tissuescaffold either before or after the body portion of the scaffold isplaced into annulus defect X.

Referring now to FIGS. 12( a) through 12(f), a technique for forming atissue scaffold having an attachment portion from a sheet of foldedmaterial is provided. In FIG. 12( a) there is provided a sheet 100 thatis a sheet of fabric or non-woven mesh material. In FIG. 12( b) a baseunit 102 is cut or stamped from sheet 100. Base unit 102 has attachmentportion 104 formed by a first lateral tab 105 and an opposite secondlateral tab 106. Base 102 further includes a non-folded body portion 103that has an upper portion 107 that extends upwardly from attachmentportion 104 and a lower portion 108 that extends downwardly from itsjunction with attachment portion 104. Base unit 102 further includesrelief portions adjacent the junctions between non-folded body portion103 and the attachment portion 104 to facilitate folding.

As shown in FIG. 12( c), the upper and lower portions 107, 108 of bodyportion 103 have each been folded in half, and then folded along foldline 109, 110, respectively, with respect to attachment portion 104 soas to extend outwardly from attachment portion 104 as shown by thefolded body portion 103′ in FIG. 12( d). As shown in FIG. 12( e) a bodyportion for a tissue scaffold can be placed between upper and lowerportions 107′, 108′ of holding portion 103′. Upper and lower portions107′, 108′ are then attached to one another by threads to hold the bodyof the tissue scaffold in holding portion 103′. Scaffold 102 may then beinserted into the annulus defect as shown in FIG. 12( f), and theattachment portion 104 sutured, tethered, stapled, or otherwise securedto the soft or hard tissue adjacent to defect X.

While one technique for forming a tissue scaffold is provided above, itshould be understood that the tissue scaffolds of the present inventioncan be fabricated by any technique as would occur to those skilled inthe art to which the invention relates.

While embodiments of the invention have been illustrated and describedin detail in the drawings and foregoing description, the same is to beconsidered as illustrative and not restrictive in character, it beingunderstood that all changes and modifications that come within thespirit of the invention are desired to be protected.

1. A spinal repair system for repairing an annulus defect of a spinaldisc, comprising: a scaffold formed as a plug for filling substantiallythe entire volume of the defect, said scaffold having an outer endaligning with or extending outward from a surface of the annulus and aninner end; first and second anchors, each of said anchors having a firstend, a second end and a shank between said ends, said shank beingcylindrical, said first end being circular and concentric with saidshank, and said second end having a point, and wherein said anchors eachhave a respective hole adjacent said first end having a diameter lessthan the diameter of said shank; and a flexible attachment member, saidmember having a portion within said scaffold, said member exiting saidscaffold at a first point and extending through said hole of said firstanchor and returning to and entering said scaffold at a second pointadjacent said first point, said member exiting said scaffold at a thirdpoint and extending through said hole of said second anchor andreturning to and entering said scaffold as a fourth point adjacent saidthird point.
 2. The system of 1, wherein said member is a suture.
 3. Thesystem of 1, wherein said member exits said scaffold at fifth and sixthpoints outside the annulus in two free ends, and said free ends we tiedtogether.
 4. The system of 1, wherein the respective shanks of saidanchors are non-threaded and include barbs.
 5. The system of 1, whereinsaid annulus defect is adjacent a spinal disc nucleus, and said scaffoldinner side is adjacent the nucleus.
 6. The system of 1, wherein saidannulus defect is adjacent a spinal disc nucleus, and said scaffoldinner side is adapted to contact the nucleus.
 7. The system of 1,wherein said scaffold is composed of a uniform composite with at leastone resorbable phase and at least one non-resorbable phase.
 8. Thesystem of 1, wherein said scaffold is adapted to conform to the innervolume of the defect.
 9. The system of 1, wherein said scaffold, saidanchors and said member are pre-assembled, prior to use in a surgery.10. The system of 1, wherein said member travels in a continuous mannerfrom said scaffold to and through said hole of said first anchor thenthrough said scaffold and to and through said hole of said second anchorthen into said scaffold.
 11. The system of 1, further comprising anartificial disc member connected to said attachment member so that saidartificial disc member is movable with respect to said attachmentmember.
 12. The system of claim 1, wherein at least one of said anchorsare adapted for implantation in bone so that all of said at least oneanchor is below the surface of said bone.
 13. A method of repairing adefect in an annulus of a spinal disc, comprising: providing the systemaccording to claim 1; placing the first anchor into a first vertebraadjacent the annulus and the second anchor into a second vertebraadjacent the annulus; positioning the scaffold in the defect; andsecuring the free ends of the attachment member.
 14. The method of claim13, further comprising forming a first hole in the first vertebra and asecond hole in the second vertebra, wherein the placing includesinserting the first anchor into the first hole and the second anchorinto the second hole.
 15. The method of claim 13, wherein thepositioning includes pulling the attachment member through the scaffold.16. The method of claim 15, wherein the pulling does not pull portionsof annulus tissue toward each other.
 17. The method of claim 13, whereinthe positioning includes compressing the scaffold to facilitate thepositioning.
 18. The method of claim 13, wherein the securing comprisestying said attachment member.
 19. The method of claim 13, wherein thefirst and second vertebrae have respective endplates, and the placing ofthe anchors includes placement so that no part of the anchors extendsfrom their respective vertebral endplates.
 20. The method of claim 13,further comprising connecting the attachment member to an artificialdisc member so that the artificial disc member is movable with respectto the attachment member.